Actively Recruiting
Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol
Led by Christian Grønhøj Larsen · Updated on 2026-01-27
165
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Christian Grønhøj Larsen
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with thyroid nodules classified as Bethesda IV and smaller than 2 cm to evaluate an alternative to immediate surgery called active surveillance. This approach aims to reduce the risks, costs, and long-term effects associated with surgery, such as hypothyroidism and nerve damage, while monitoring safety and disease progression. The study will track how many patients experience disease progression or require surgery over a five-year period. Participants will undergo active surveillance involving regular ultrasound scans and clinical check-ups at 6, 12, 18, 24, 36, 48, and 60 months instead of having immediate surgical removal of the thyroid nodule. This non-surgical approach is designed to observe the nodule for any changes that may indicate the need for surgery while preserving thyroid function and minimizing overtreatment. During the study, participants will have periodic ultrasound imaging and clinical evaluations to monitor their thyroid nodules. Researchers will assess the number of patients who need surgery or show disease progression at 1, 2, and 5 years. Patient safety, feasibility of surveillance, and patient experience will be evaluated throughout the study, which lasts for five years from enrollment to the end of follow-up.
CONDITIONS
Brief Title
Active Surveillance for Bethesda IV Thyroid Nodules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 30 years or older
- A single thyroid nodule classified as Bethesda IV (follicular neoplasm or suspicious for follicular neoplasm)
- Tumor size less than 2 cm in all dimensions
- EU-TIRADS 3 or 4 on ultrasound imaging examination
You will not qualify if you...
- EU-TIRADS 5 on ultrasound imaging examination
- Suspicion of disseminated disease due to PET-positive lymph nodes, suspicious lymph nodes by ultrasound or CT scan, capsular invasion, irregular tumor shape or margins, or extrathyroidal growth
- Tumor located at a high-risk site near vessels, recurrent laryngeal nerve, or trachea with extracapsular extension
- Previous thyroid surgery
- Concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol/L)
- Pregnancy
- Unable to give informed consent
- Elevated calcitonin above normal levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants undergo active surveillance of thyroid nodules with ultrasound and clinical follow-up instead of surgery.
Follow-up visits at 6, 12, 18, 24, 36, 48, and 60 months
Trial Site Locations
Total: 1 location
1
Department of Otolaryngology, Head and Neck SurgeryRigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
N
Nicoline Thorup, MD, PhD Fellow
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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